The effectiveness of a newly developed Zendium dentifrice in the treatment of gingivitis.

Background: Control of plaque on the tooth surfaces is the most important
method of controlling dental disease. A manual toothbrush is the most popular
mechanical method of plaque control. In spite of the activity in improving
toothbrush type and design, most people still remove only approximately 50% of
the plaque present when they brush their teeth (Jepsen 1998). The development
of a dentifrice that would allow the average person to control plaque and
gingivitis would be desirable.

Aim: The aim of the present study was to evaluate the effect of a colostrum &
zinc-containing Zendium dentifrice on gingivitis in an 8-week clinical trial.

Material and methods: The study is designed to evaluate the effect of a
colostrum & zinc-containing Zendium dentifrice on gingivitis in an 8-week
clinical trial. 180 subjects (non-dental) will be selected on the basis of
having moderate gingival inflammation. At baseline, plaque (Quigley & Hein),
bleeding upon marginal probing (BOMP), and gingival abrasion (GA) will be
assessed. Subjects will be randomly divided among 3 groups; group 1 will brush
with a Zendium toothpaste with enzymes, colostrum, a low concentration zinc and
with lysozyme, group 2 will brush with a control dentifrice with fluoride and
group 3 will brush with a Zendium toothpaste with enzymes, colostrum, a low
concentration zinc and without lysosym. All groups will brush with a normal
manual toothbrush. After 4-weeks and after 8-weeks the clinical indices will
be assessed again. At each assessment the participants will receive a new
manual toothbrush.

Intervention: Improvement of gingival health by removing plaque and avoiding
gingival abrasion with the manual toothbrush and zinc containing toothpaste.

Risk for subjects: none.